CSRC Annual Meeting: 10 Years of Excellence

7:30am-8:00am Breakfast

8:00am- 8:05am Welcome and Introduction- Philip Sager, MD (Stanford University)

8:05am-8:45am Plenary Session I: The future of drug and device development: balancing benefit and risk – Janet Woodcock, MD (FDA) (20min)

Moderators: Mitchell Krucoff, MD (Duke University Medical Center), Norman Stockbridge MD, PhD (FDA)

Discussion (20min)

8:45am-11:20am Session II: Role of publicprivate partnerships

Moderators- Ignacio Rodriguez, MD (Roche), Rick Turner, PhD, DSc (QuintilesIMS)

  • CSRC- What has been contributed over the last 10 years
    • Brief history of the CSRC and Overview of accomplishments and areas of impact – Mitchell Krucoff, MD (Duke University Medical Center)(20min)
      • Regulatory impact- QT and CIPA, anticoagulants for NOAC’s, CRF forms, Outcome Studies, White Papers
      • Relationships with other organizations (include DIA relationship, Cardio-Oncology, Pediatric CV Safety) and regions
    • Impact of public-private partnerships in cardiology- Norman Stockbridge, MD, PhD (FDA)(15min)
    • MDEpiNet: lessons learned- Jesse Berlin, ScD (Johnson & Johnson)(15min)
    • CTTI (Clinical Trials Transformation Initiative): lessons learned- Annemarie Forrest, RN, MS, MPH (Duke University Medical Center)(15min)
    • How can working together be enhanced?

Discussion (60min)

Lunch 11:20pm-12:30pm

12:30pm-2:00pm Session III: Updates on Think Tanks- Impact and what has occurred since

Moderators- Jonathan Seltzer, MD, MBA (ACI Clinical), Thomas Todaro, MD, (MedPace)

  • CV Outcomes Think Tank
    • CV Outcomes Think Thank and current status DM outcome trials White Paper- Rick Turner, PhD, DSc (QuintilesIMS)(15 min)
    • Mu-opioid receptor Advisory Committee Meeting- Peter Kowey, MD (Lankenau Medical Center)(15min)
    • Reversal agents for NOAC’s- Paul Reilly, PhD (Boehringer Ingelheim)(15min)

Discussion (45min)

Break: 2:00pm-2:10pm

 2:10pm-3:15pm Session IV: Updates on Think Tanks Moderators: Philip Sager, MD (Stanford), Peter Kowey, MD (Lankenau Medical Center)

  • Prevention of Sudden Cardiac Death in the Young Salim F. Idriss, MD, PhD (Duke University Medical Center)(15min)
  • Phase 1 ECG assessment – focus on Think Tank to a collaborative research study to ICH revision- Borje Darpo, MD, PhD (iCardiac Technologies)(10min)
  • CiPA Effort- Gary Gintant, PhD (Abbvie)(10min)

Discussion (30min)

 3:15pm-4:15pm Discussion of potential future CSRC areas of focus and opportunities

Moderators- Theressa Wright, MD (Eli Lily), Mary Jane Geiger, MD (Regeneron)

  • Survey Results.

Panel Discussion

Panelist:

  • Mitchell Krucoff, MD (Duke University Medical Center)
  • Norman Stockbridge, MD, PhD (FDA)
  • Kaori Shinagawa, MD (PMDA)
  • Peter Kowey, MD (Lankenau Medical Center)
  • Philip Sager, MD (Stanford University)